Post Market Quality Technician

Job Title: Post Market Quality Technician
Work Type: Acton MA 01720

Duration: 04 months+ contract
Pay Rate: 32$/hr. On W2

The Post Market Quality Technician plays an integral role in Insulet’s Quality Department as a hands-on engineering role conducting post market investigations of FDA-approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross-functional teams, and drive to accomplish departmental and company goals.

Responsibilities:

• Perform moderately complex tasks to ensure compliance with quality standards
• Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained
• Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA
• Perform product testing and failure analysis
• Review Lot Acceptance records and DHRs
• Collect log quality data and trend results
• Accountability for quality data entry and productivity
• Assist in gathering information during FDA and ISO 13485 inspections
• Trouble shoot new failure modes.
• Evaluate process and engineering controls to improve safety and efficiency.
• Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

• Associates Degree in an engineering, or scientific discipline

Preferred Skills and Competencies:

• Electrical and mechanical background strongly preferred
• Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred
• Preferred 2 years in a Quality related function, working with QSR and/or ISO 13485
• Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plus
• Ability to organize and complete tasks with minimal supervision
• Excellent technical writing skills
• Excels at generating and maintaining organized and accurate records
• Experience with Lean Six Sigma methodology a plus

Physical Requirements (if applicable):

• Sitting 70%, Standing 30%
• Frequent lifting <5lbs
• Occasional (<10% of time) handling (push/pull) up to 50lbs
• Ability to operate basic hand tools

NOTE: This position requires on-site working arrangements (requires on-site office/plant/lab work).